Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer
Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer
Intervention: Valproic Acid (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s):
Electron Kebebew, MD, Principal Investigator, Affiliation: University of California, San Francisco
Summary
RATIONALE: Drugs such as valproic acid may make thyroid cancers more radioiodine sensitive,
which will allow for detection of tumor and make further ablation treatment effective.
Clinical Details
Official title: A Phase II Trial of Valproic Acid (Depakote ER ®) in Patients With Advanced Thyroid Cancers of Follicular Origin, Who Are Thyroglobulin Positive/RAI Unresponsive
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Decrease in Thyroglobulin LevelDecrease in Tumor Size
Secondary outcome: Increased Radioactive Iodine UptakeSide Effects of Drugs Affecting Quality of Life Survival
Detailed description:
PURPOSE: This phase II trial is studying how well valproic acid works in treating patients
with thyroid cancers that do not respond well to other treatments.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
INCLUSION CRITERIA:
DISEASE CHARACTERISTICS
- Diagnosis of advanced/poorly differentiated thyroid cancer of follicular cell origin
that is radioiodine-unresponsive
- Cumulative dose of radioiodine < 800 mCi
- No radioiodine uptake on whole body scan within 18 months of enrollment
- Inoperable extensive locoregional tumor mass and/or metastatic spread
- Failed conventional therapy that included total thyroidectomy AND radioactive iodine
I 131 ablation
- Elevated thyroglobulin level (>2ng/ml on thyroid hormone, >10ng/ml off thyroid
hormone)or Tg-antibody positive
PATIENT CHARACTERISTICS
- 18 years or older
Entry lab results:
- Hemoglobin > 8. 0 gm/dl
- Absolute Neutrophil Count > 750 cells/mm3
- Platelet count > 75000/mm3
- BUN < 1. 5 times upper limit of normal (ULN)
- Creatinine < 1. 5 times ULN
- Total protein > 6. 4
- Total bilirubin should be < 1. 5 times ULN.
- AST (SGOT), ALT (SGPT), ALKP and amylase < 1. 5 times ULN
- Amylase < 1. 5 times ULN
- Albumin > 2. 5
- Ammonia < 1. 5 times ULN
EXCLUSION CRITERIA:
- Not pregnant
- No nursing within the past 3 months
- No allergy to valproic acid
- No coexisting malignancy other than basal cell carcinoma
- No hepatic disease or significant dysfunction
- Karnofsky score > 80
- No pancreatitis
- No kidney dysfunction
- Fertile patients must use effective contraception
Locations and Contacts
UCSF Comprehensive Cancer Center, San Francisco, California 94115, United States
Additional Information
Starting date: August 2007
Last updated: January 21, 2015
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